REGULATORY AFFAIRS GLOBAL LABELING LEAD

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients.
Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
Why IQVIA Making a positive impact on human health takes insight, curiosity, and intellectual courage.
It takes brave minds, pushing the boundaries to transform healthcare.
In your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and, ultimately, improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learning.
Role.
Regulatory Affairs Global Labeling Lead Location.
Europe Work Arrangement.
Home based Role Overview You will oversee all labelling activities for specified APIs and collaborates with our client and/or IQVIA stakeholders, such as Global Labeling, PV, GRLs and the LOCs (Local Operating Companies) to ensure regulatory compliance for these APIs.
Responsibilities Completes all labelling deliverables within the required timelines (including those relating to PSMF).
Investigates specified APIs proposed for CCDS creation/revision/withdrawal Leads the CCDS creation/revision process and co-ordinates the CCDSworking team (CCDS-WT).
Leads the USPI (United States Prescribing Information) revision process and co-ordinates the Labeling Working Group (LWG) Assesses labelling issues, including alignment with CCDS and alignment to FDA Labeling guidance Endorses Prescribing Information and Patient Information content prior to final approval.
Organises a back-up for planned absences.
Keeps the IQVIA API/ Product Listing up-to-date for the products for which he/she is the GLL.
Operates to QMS documents and non-QMS documents for the regulatory services provided.
Proposes improvements to the current client QMS procedures to the EPIC RA Labeling Lead.
Conducts quality control (QC) review for deliverables prepared by other GLLs.
Raises suspected quality issues and process deviations with the EPIC RA Labeling Lead.
Escalates LOCs non-adherence to the Local exception forms, deferral request form and RIM System ‘PRISM Data Entry Form (PDEF)’s in accordance with the timelines and/or to submission timeline according to the agreed Escalation Plan for LOCs.
Enters own labeling-related tasks in the IQVIA internal Project Management tool.
Reviews all open deliverables on a weekly basis and updates as applicable Updates the deliverables information and moves status to “Complete” when the deliverable is complete.
Do you meet the skills, experience, and educational requirements of the role? Expeirnece of managing regulatory Projects (Required) Regulatory labelling expeirnece with the EMEA / North America region.
(Required) Extensive pharmaceutical Regulatory affairs experience typically demonstrated by 5 or more years Woking in the pharmaceutical industry.
(Required) Excellent communication and written skills in English (Required) BSc or equivalent in a scientific or related field (Required) At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world.
The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our + employees around the world who apply their insight, curiosity and intellectual courage every step of the way.
Learn more at jobs.
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IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward.
Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities.
No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health.
Thank you for your interest in growing your career with us.